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Date: 16th June, 2008

Location: Webe Seminars, USA

Summary:
Clinical, Pharmaceutical - Training

Analytical methods are a major tool used in pharmaceutical development to control the quality and integrity of the active drug substance or drug product. Methods are normally developed at one site and then transferred to one or more sites during the drug development process. Qualifying analysts to perform these methods is a critical activity that will significantly impact the launch of a product. Activities of a method transfer process must be managed effectively to deliver an analytical method from one site or department to another.

This 2-session webinar series will present fundamental principles of a method transfer, examine different strategies, and discuss key factors that will influence the transfer of analytical methods from one site to another.

Session 1 [16 June]: Understanding Method Transfer Process
Purpose of Analytical Method Transfer
Strategies of Method Transfer
Phases of Method Transfer
Contents of Method Transfer package
Determine impacts on the Transfer process

Session II [23 June]: Establishing Method Transfer Protocol
Selecting a Method Transfer team
Developing Method Transfer protocol
Determining appropriate acceptance criteria
Evaluating and documenting Transfer data
Handling investigations of Transfer failures